1 Chapter 1: An Overview of Medical and Regulatory Writing
Introduction
Medical communication can probably be dated back
to local healers and shamans’ oral traditions passed
on to their families and apprentices. Regulation of
these also probably date back to the enforcement of
various dogmas with societal and religious teachings.
The evolution of current authoring, submission, and
review of regulatory documentation has its roots in
the 1980s. That decade marked a time of significant
change in how drugs were approved, which took
place alongside, and some times drove, advances in
document and authoring technology. In the United
States (US), legislative actions on the Code of
Federal Regulations (CFR) marked the beginning of
significant developments in marketing applications’
requirements that led to the current International
Council for Harmonisation (ICH) environment.
The rise of better authoring technology included the
change from dedicated word processors to net-
worked personal computers, the shift from hard copy
submissions to electronic submissions, and how drug
candidate reviews are performed and funded.
I began my career as a regulatory medical writer
at a pivotal juncture in the field. In 1991, I answered
an ad posted by Wyeth-Ayerst Research, Inc. on
the Prodigy® online service requesting people with
doctorates in clinical or life sciences who had pub-
lished journal articles. At the time, I had been doing
postdoctoral work in biology at the University of
Pennsylvania and did not know that getting employ-
ment from an online service was unusual. Being a
basic sciences researcher, I had little knowledge of
clinical research or medical writing. For example, I
was unaware that harmonization of drug develop-
ment documents was an issue and that ICH had
begun work that would change my career track
before I had even started in the industry and would
change the face of regulatory writing worldwide.
My first task as a medical writer was to edit
Summary Basis of Approval (SBA) documents to be
incorporated into New Drug Applications (NDAs)
to the US Food and Drug Administration (FDA).
At that time, the SBA could be submitted with the
NDA and was developed collaboratively with FDA
reviewers as part of the drug approval process.1 Even
though I had never heard these terms, working on
these documents essentially defined me as a regula-
tory medical writer from the start.
Many people have entered the regulatory writ-
ing profession after I did. There are many things that
more recent entrants into the field take for granted
that were significant changes at the time. The fol-
lowing narrative will describe the regulatory writing
environment in the 1980s and document some of
the key changes and their effects on the regulatory
writing landscape.
1
An Overview of Medical and
Regulatory Writing
By Danny A. Benau, MSOD, PhD
Introduction
Medical communication can probably be dated back
to local healers and shamans’ oral traditions passed
on to their families and apprentices. Regulation of
these also probably date back to the enforcement of
various dogmas with societal and religious teachings.
The evolution of current authoring, submission, and
review of regulatory documentation has its roots in
the 1980s. That decade marked a time of significant
change in how drugs were approved, which took
place alongside, and some times drove, advances in
document and authoring technology. In the United
States (US), legislative actions on the Code of
Federal Regulations (CFR) marked the beginning of
significant developments in marketing applications’
requirements that led to the current International
Council for Harmonisation (ICH) environment.
The rise of better authoring technology included the
change from dedicated word processors to net-
worked personal computers, the shift from hard copy
submissions to electronic submissions, and how drug
candidate reviews are performed and funded.
I began my career as a regulatory medical writer
at a pivotal juncture in the field. In 1991, I answered
an ad posted by Wyeth-Ayerst Research, Inc. on
the Prodigy® online service requesting people with
doctorates in clinical or life sciences who had pub-
lished journal articles. At the time, I had been doing
postdoctoral work in biology at the University of
Pennsylvania and did not know that getting employ-
ment from an online service was unusual. Being a
basic sciences researcher, I had little knowledge of
clinical research or medical writing. For example, I
was unaware that harmonization of drug develop-
ment documents was an issue and that ICH had
begun work that would change my career track
before I had even started in the industry and would
change the face of regulatory writing worldwide.
My first task as a medical writer was to edit
Summary Basis of Approval (SBA) documents to be
incorporated into New Drug Applications (NDAs)
to the US Food and Drug Administration (FDA).
At that time, the SBA could be submitted with the
NDA and was developed collaboratively with FDA
reviewers as part of the drug approval process.1 Even
though I had never heard these terms, working on
these documents essentially defined me as a regula-
tory medical writer from the start.
Many people have entered the regulatory writ-
ing profession after I did. There are many things that
more recent entrants into the field take for granted
that were significant changes at the time. The fol-
lowing narrative will describe the regulatory writing
environment in the 1980s and document some of
the key changes and their effects on the regulatory
writing landscape.
1
An Overview of Medical and
Regulatory Writing
By Danny A. Benau, MSOD, PhD